FDA launches AI action plan to harness ‘enormous potential’ in medical devices

By Jamie Bell

13 Jan 21

A new FDA action plan regarding AI involves further development of proposed regulatory frameworks and fostering a patient-centred…

RegulationRegulatory Policy

IVDR: What will these new EU regulations mean for in vitro diagnostics manufacturers?

By Jamie Bell

08 Jan 21

In 2022, the long-standing IVDD will be replaced by the IVDR, ushering in a new era regarding how…

RegulationApprovals

New UK medical device database will create ‘hugely valuable resource’ for businesses and hospitals alike

By Jamie Bell

05 Jan 21

The UK recently adopted the GMDN classification system as part of its new medical device database, which came…

RegulationRegulatory Policy

FDA issues face mask warning after patient is burned during MRI scan

By Jamie Bell

10 Dec 20

The FDA has stated that, while face masks may need to be worn during MRI scans due to…

RegulationRegulatory Policy

The challenge of embedding security and privacy into a medical device

By Peter Littlejohns

12 Nov 20

An evolving cyber threat landscape and complex privacy laws create challenges for medical device companies looking to add…

Regulatory PolicyRegulation

FDA commissioner encourages diversity and inclusivity in clinical trials

By Jamie Bell

10 Nov 20

Dr Stephen Hahn has emphasised the need for sponsors and researchers to ensure diversity, and representation of all…

RegulationRegulatory Policy

AdvaMed issues medtech industry principles to address racial health disparities

By Peter Littlejohns

30 Oct 20

The document laying out its new principles involves an acceptance that "deep rooted" systems of racism and inequity…

Regulatory PolicyRegulation

A closer look at Joe Biden’s vision for ‘rebuilding’ US supply chains

By Jamie Bell

29 Oct 20

Democratic candidate Joe Biden will attempt to boost domestic manufacturing and make US supply chains 'more resilient' in…

RegulationRegulatory Policy

MHRA joins forces with regulators in Australia, Canada, Singapore and Switzerland

By Jamie Bell

17 Oct 20

The MHRA is joining the ACSS Consortium, and will begin working with regulators from Australia, Canada, Singapore and…

RegulationRegulatory Policy

FDA establishes new centre to support digital health devices

By NS Medical Staff Writer

25 Sep 20

The new centre will advance the mobile health devices, Software as a Medical Device (SaMD), wearables medical devices,…

DevicesRegulationRegulatory Policy